COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - revoked 28 April 2023

Last updated: 28 April 2023

The COVID-19 Public Health Response (Point-of-care Tests) Order 2021 came into force 22 April 2021 and was revoked on 28 April 2023. This order had prohibited a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless approved by the Director-General of Health.

From 28 April 2023, point-of-care tests (POCTs) can be manufactured, imported and provided for sale without the requirement for approval under the POCT Order. 

On 11 May 2023, the Director-General of Health Dr Diana Sarfati revoked the previous notices associated with the now former point-of-care tests. This notice can be found here: Revocation of Director-General Notices (PDF, 36 KB), and on the Gazette New Zealand website.

The previous order had replaced the Notice Under Section 37 of the Medicines Act 1981 (Gazette 2020-go1737) and broadened the group of Point-Of-Care tests the restrictions applied to.

The evaluation and authorisation framework used under the POCT Order can be found here: 

If you have any queries about the previous approval process, please email: [email protected]

Rapid antigen tests approved under the previous POCT Order

Product name(s) 

Sample type(s) 

Product configuration 

Video and PDF instructions for use 

Gazette notices
AllTest COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV802H) Self Test, JusChek COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV802H) Self Test, and Beright COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV-802H) Self Test Oral Fluid (saliva) Professional or self-test of any package size Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 22 KB)

Rapid SARS-CoV-2 Antigen Test Card

MP Biomedicals Asia Pacific Pte Ltd. (Singapore)

Nasal, nasopharyngeal and oropharyngeal swab

Professional use of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 23 KB)

Roche SARS-CoV-2 Rapid Antigen Test (SD Biosensor) 

SD Biosensor (Republic of Korea) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

PanBio COVID-19 Ag Rapid 

Abbott Rapid Diagnostics Jena GmbH (Germany) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

CareStart COVID-19 Antigen 

CareStart COVID-19 home test

Access Bio Inc (United States of America) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

Atomo COVID-19 Antigen Test 

Access Bio Inc (United States of America) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

CLINITEST Rapid COVID-19 Antigen Test 

Healgen Scientific Limited Liability Company (United States of America) or Zhejiang Orient Gene Biotech Co., Ltd (China)

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

Healgen Rapid COVID-19 Antigen Test and Orient Gene Rapid COVID-19 Antigen Test 

Healgen Scientific Limited Liability Company (United States of America) or Zhejiang Orient Gene Biotech Co., Ltd (China) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

BD Veritor System for Rapid Detection of SARS-CoV-2 and BD kit for rapid detection of SARS-CoV-2 (visually read) 

Becton, Dickinson and Company (United States of America) 

Nasal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

Sofia SARS Antigen FIA Test kit with Sofia and Sofia 2 analyser 

Quidel Corporation (United States of America) or Puritan Medical Products Company LLC (United States of America) 

Nasal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

Ecotest COVID-19 Antigen Nasal Test Kit

Assure Tech (Hangzhou) Co Ltd (China) 

 

Nasal swab or nasal pen 

Professional or self-test of any package size 

Please note the Ecotest SARS-CoV2 test is not recommended for use in children under the age of 2 years

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

STANDARD Q COVID-19 Ag Test 

STANDARD i-Q COVID-19 Ag Home Test 

SD Biosensor (Republic of Korea) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

GenBody COVID-19 Ag Test 

GenBody Inc. (Republic of Korea) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)

BIOCREDIT COVID-19 Ag Home Test

RapiGEN Inc. (Republic of Korea)

Nasal Professional or self-test of any package size Expansion to Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 15 March 2022 (PDF, 22 KB)

FlowFlex SARS-CoV-2 Antigen Rapid Test

ACON Biotech (Hangzhou) Co., Ltd. (China)

Nasal

Professional or self-test of any package size

Expansion to Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 31 March 2022 (PDF, 22 KB)

Zybio SARS-CoV-2 Antigen Assay Kit

Zybio Inc. (China)

Nasal swab

Self-test of any package size 

  • Zybio SARS-CoV-2 Antigen Assay Kit instructions for use 
Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 22 April 2022 (PDF, 22 KB)

StrongStep SARS-CoV-2 Antigen Rapid Test

Nanjing Liming Bio-Products Co., Ltd (China)

Nasal swab  Professional or self-test of any package size 

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 30 KB)

CLUNGENE COVID-19 Antigen Rapid Test

Hangzhou Clongene Biotech Co., Ltd (China)

Nasal swab Self-test of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 30 KB)

INDICAID COVID-19 Rapid Antigen Test

PHASE Scientific International, Ltd. (Hong Kong and United States of America)

 

Nasal swab Professional or self-test of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 30 KB)

SARS-CoV-2 Antigen Kit (Colloidal Gold)

Goldsite Diagnostics, Inc. (China)

Nasal swab Self-test of any package size Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 20 – 26 May 2022 (PDF, 22 KB)

OnSite COVID-19 Ag Rapid Test

CTC Biotech Inc, (United States of America)

Nasal swab Self-test Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 22 August 2022 (PDF, 22 KB)

AllTest SARS-CoV-2 Antigen Rapid Test

Hangzhou Alltest Biotech Co Ltd, (China)

Nasal swab

Professional or self-test of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)

JusChek SARS-CoV-2 Antigen Rapid Test

Hangzhou AllTest Biotech Co., Ltd. (China)

Nasal swab

Professional or self-test of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)

BeRight SARS-CoV-2 Antigen Rapid Test

Hangzhou AllTest Biotech Co., Ltd. (China)

Nasal Swab

Professional or self-test of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)

Gold Standard Diagnostics (GSD) SARS-CoV-2 Antigen Rapid Test

Hangzhou AllTest Biotech Co., Ltd. (China)

Nasal swab

Self-test of any package size

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB)

Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)

LumiraDx SARS-CoV-2 Ag Test

LumiraDx UK Ltd (United Kingdom) 

Nasal, nasopharyngeal swab  Professional use only of any package size Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 21 December 2022 (PDF, 22 KB)

LAMP tests approved under the previous POCT Order

Product name(s)  Lucira CHECK-IT COVID-19 Test Kit and Lucira COVID-19 All-in-One Test Kit 
Manufacturer (country)  Lucira Health, Inc. (United States of America) 

Sample type(s) 

Nasal swab 
Product configuration  Self-test of any package size 
Approved 8 June 2022

Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 22 KB)

Other Molecular Point-of-Care Tests approved for use (PDF, 32 KB)

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